EUCTR2019-002020-33-NL进行中(未招募)1 期
Pentoxifylline dose optimization in neonatal sepsis. - Pentoxifylline in neonatal sepsis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Neonates with gestational age <30 weeks
- •- Suspected of sepsis with blood drawn for blood culture and inflammatory biomarkers
- •- IL-6 > 500 pg/ml or if CRP > 50 mg/L
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- PTX therapy cannot be started within 24 hours of start of antibiotic treatment.
- •- Patients with major congenital defects (e.g. congenital heart disease, pulmonary, or gastrointestinal anomalies) will also be excluded.
- •- If subjects have IL-6 values exceeding 25000 pg/mL at time of onset they will also be excluded. High IL-6 values represent severe episodes of sepsis and high IL-6 values are associated with high mortality rates.
- •- Patients who already participated in this trial during an earlier episode of late onset sepsis.
- •- Patients with pH below 7 in two consecutive blood samples, with at least 1 hour between the blood samples, at start of sepsis episode.
研究者
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